PediatricPhase 4EEIDRNCT06303037

Effect of Esketamine on 95% Induction Dose of Remimazolam

A Phase 4 study testing Remimazolam besylate and low-dose Esketamine and Remimazolam besylate and Medium dose Esketamine in people with Pediatric and Gastroscopy, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 3 to 12 yearsHealthy volunteers can take part
Conditions the study is for: Pediatric, Gastroscopy, ED95
What is being tested?: Remimazolam besylate and low-dose Esketamine and Remimazolam besylate and Medium dose Esketamine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteChina
Study dates: 1 Apr 2024to 1 Dec 2024
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 3 to 12 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

with American Society of Anesthesiologists (ASA) physical status I or II#;
aged 3#12 years#;
children with weight for age within the normal range#;
were scheduled to have a gastroscopy;

Who cannot join

Children who had gastrointestinal,Cardiovascular or endocrine dysfunction;
contraindication to preoperative sedation or had a known allergy or hypersensitive reaction to remimazolam and esketamine;
recently respiratory infection, mental disorder;
other reasons that researchers hold it is not appropriate to participate in this trial.

Trial locations and contacts

1 site in 1 country.

China1 site

The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang

Other trials in China

About this study

Official title: Determination of the 95% Effective Dose of Remimazolam in Combination With Different Doses of Esketamine During Gastroscopy in Children

As an invasive operation, gastroscopy will cause children's nervousness, anxiety and uncooperative behavior, and even lead to the risk of bleeding and perforation, which will also affect the accuracy of the examination results.The purpose of this study is to explore the influence of different doses of esketamine on the induced dose ED95 of remazolam during gastroscopic placement in children, and to provide theoretical basis for the combined use of remimazolam besylate and esketamine in gastroscopic anesthesia in children.

Read the detailed description

Children aged 3-12 who underwent gastroscopy were randomly divided into two groups: L group with Esketamine 0.25mg/kg and the initial dose of Remimazolam was 0.3mg/kg ,M group with Esketamine 0.5mg/kg and the initial dose of Remimazolam was 0.2mg/kg.Judging whether the sedation level of the children can meet the requirements of gastroscopy placement after injecting Remimazolam.The next dose was adjusted to 0.05mg/kg according to biased coin design,to further explore the induced dose of ED95 of Remimazolam under the background of different doses of Esketamine.

Conditions: Pediatric, Gastroscopy, ED95, Sedation
Being tested: Remimazolam besylate and low-dose Esketamine, Remimazolam besylate and Medium dose Esketamine
Keywords: remimazolam, esketamine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Remimazolam besylate and low-dose EsketamineDrug
Also called intravenous bolus remimazolam according to biased coin design
Esketamine was injected intravenously 0.25mg/kg and the initial dose of Remimazolam was 0.3mg/kg
Remimazolam besylate and Medium dose EsketamineDrug
Also called intravenous bolus remimazolam according to biased coin design
Esketamine was injected intravenously 0.5mg/kg and the initial dose of Remimazolam was 0.2mg/kg

Study groups in NCT06303037
Study group	Role	What they receive
Group L	Experimental	Low-dose esketamine Receives: Drug: Remimazolam besylate and low-dose Esketamine
Group M	Experimental	Medium dose esketamine Receives: Drug: Remimazolam besylate and Medium dose Esketamine

What is being measured

The primary outcome is the main question the study is designed to answer.

Sedation induction time
the patients' unresponsiveness to the mild shaking of their shoulder
Measured: during anaesthetic induction

Secondary outcomes (4)

Modified observer's assessment of alertness#sedation#MOAA/S#scale
5#Subject responds readily to name spoken in a normal tone; 4 #Lethargic response of a subject to a name spoken in a normal tone; 3 #The subject responds only after a name is called loudly and repeatedly; 2 #The subject responds only after mild prodding or shaking;
1 #The subject responds only after a painful trapezius squeeze; 0 #The subject does not respond to painful trapezius squeeze. MOAA/S score ≤ 2 points represent successful sedation
Measured: 1 minutes after single intravenous bolus remimazolam
Recovery times
The time from discontinuation of anesthesia drug to the first open eye of the children and to achieve aldrete≥9
Measured: Within up to 30 minutes after operation
VAS(The difficulty of gastroscope insertion)
VAS values range from 0 to 10. A value of 0 represents that gastroscopy placement is very easy.and 10 represents that gastroscopy placement is very difficult.
Measured: Moment of endoscopic insertion
Number of children with adverse effects
Bradycardia and/or hypotension need for hemodynamic support Desaturation is defined as Oxygen desaturation <90% Any adverse effects requiring interventions
Measured: Within 24 hours after completion of gastroscopy.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 20241 Dec 2024

First posted12 Mar 2024
Study start1 Apr 2024
Primary completion29 Aug 2024
Study completion1 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for PediatricStudies of the same condition, open and under way.
More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06303037
Sponsor's protocol ID: SAHoWMU-CR2024-03-105
Acronym: EEIDR
Status last verified: Feb 2025
First submitted: 25 Jan 2024
Last updated: 6 Feb 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Determination of the 95% Effective Dose of Remimazolam in Combination With Different Doses of Esketamine During Gastroscopy in Children
ClinicalTrials.gov ID: NCT06303037
Acronym / sponsor ID: EEIDR / SAHoWMU-CR2024-03-105
Conditions: Pediatric, Gastroscopy, ED95, Sedation
Keywords: remimazolam, esketamine
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
Study start: 1 Apr 2024 (actual)
Primary completion: 29 Aug 2024 (actual)
Study completion: 1 Dec 2024 (actual)
First posted: 12 Mar 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Group L	Experimental	Drug: Remimazolam besylate and low-dose EsketamineLow-dose esketamine
Group M	Experimental	Drug: Remimazolam besylate and Medium dose EsketamineMedium dose esketamine

Who may qualify

Ages: 3 to 12 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

with American Society of Anesthesiologists (ASA) physical status I or II#;
aged 3#12 years#;
children with weight for age within the normal range#;
were scheduled to have a gastroscopy;

Key exclusion criteria (4 listed)

Children who had gastrointestinal,Cardiovascular or endocrine dysfunction;
contraindication to preoperative sedation or had a known allergy or hypersensitive reaction to remimazolam and esketamine;
recently respiratory infection, mental disorder;
other reasons that researchers hold it is not appropriate to participate in this trial.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Remimazolam besylate and low-dose EsketamineAlso: intravenous bolus remimazolam according to biased coin designEsketamine was injected intravenously 0.25mg/kg and the initial dose of Remimazolam was 0.3mg/kg	Drug	Group L
Remimazolam besylate and Medium dose EsketamineAlso: intravenous bolus remimazolam according to biased coin designEsketamine was injected intravenously 0.5mg/kg and the initial dose of Remimazolam was 0.2mg/kg	Drug	Group M

Primary outcome

Sedation induction time
Time frame: during anaesthetic induction
the patients' unresponsiveness to the mild shaking of their shoulder

4 secondary outcomes

Modified observer's assessment of alertness#sedation#MOAA/S#scale
Time frame: 1 minutes after single intravenous bolus remimazolam
Recovery times
Time frame: Within up to 30 minutes after operation
VAS(The difficulty of gastroscope insertion)
Time frame: Moment of endoscopic insertion
Number of children with adverse effects
Time frame: Within 24 hours after completion of gastroscopy.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.

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Not yet recruiting
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Cerebral Palsy
RecruitingPhase 3
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Huacheng Liu principal investigator

Second Affiliated Hospital of Wenzhou Medical University

Yuhang Cai principal investigator

Second Affiliated Hospital of Wenzhou Medical University

Qiaoqiao Wang principal investigator

Second Affiliated Hospital of Wenzhou Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sedation induction time (time frame: during anaesthetic induction). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06303037.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.